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BMS sues Merck over new melanoma drug

pharmafile | September 8, 2014 | News story | Research and Development, Sales and Marketing BMS, FDA, Merck, PD-1 inhibitors, Yervoy, keytruda 

Things are getting ugly between Bristol-Myers Squibb and Merck as the former company began legal proceedings against the latter over its new drug, which gained approval just last week.

In fact BMS filed the lawsuit against Merck’s new melanoma treatment Keytruda (pembrolizumab) on the same day it was approved by the FDA.

Merck was the surprise winner with Keytruda in the US race to market a new type of cancer drug known as a PD-1 inhibitor – in a lucrative market which could be worth $30 billion in the coming years.

BMS is currently developing its own PD-1 drug called nivolumab, but has yet to file this treatment with the FDA, and will not likely be on the market until the second quarter of next year.

In its lawsuit filed in the US District Court of Delaware, BMS said that Merck was planning to ‘exploit its invention’ of its new immunotherapy drug nivolumab with Keytruda, arguing that it is violating the company’s 20 May patent.

The alleged infringement relates to BMS’s patent that allows its drug to treat cancer with anti-PD-1 antibodies. Specifically, this is its 474 patent relating to how its antibody binds to the PD-1 and blocks the checkpoint pathway.

BMS has gained approval for its new drug in Japan earlier this year where it is marketed as Opdivo, but has been beaten to the more lucrative US market by Merck, its closest rival in the PD-1 race.

BMS also develops Yervoy (ipilimumab), the first immunotherapy for melanoma to be approved by the FDA.

Merck’s new drug must be used only after patients have failed on BMS’s Yervoy. If the patient has the BRAF mutation then they must also first use Yervoy and a BRAF inhibitor by GSK or Roche, and then can use Keytruda if the disease is not responding.

The official legal case is Bristol-Myers Squibb Co and Ono Pharmaceutical co ltd (its Japanese partner for the drug) versus Merck & Co Inc., US District Court, for the district of Delaware, Wilmington No. 14-CV-01131.

Ben Adams 

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